This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.
Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%. Currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD. Transient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis. 40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention. If the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.
Department of Medicine, Zealand University Hospital
Køge, Denmark
Recruitment
\>50% of those invited to participate gives written consent.
Time frame: 6 months
Retention
\>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Time frame: 6 months
Completion
\>50% of randomized patients complete follow-up
Time frame: 6 months after randomization
Reduction in Number of heavy drinking days
Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.
Time frame: 10 months
Abstinence or reduction in alcohol consumption
Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.
Time frame: 10 months
Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment
Results from fibroscan, with a mean value of \>8 indicating fibrosis and a mean value of \>15 indicating cirrhosis.
Time frame: 6 months
Reduction in AUDIT score
AUDIT score is reported at baseline, and again at the 6 months follow up phone call.
Time frame: 10 months
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